CDC and the Food and Drug Administration (FDA) have
investigated a case of Creutzfeldt-Jakob disease (CJD) in a
28-year-old woman who died 22 months after receiving a
lyophilized, irradiated human cadaveric dura mater graft. They
found that the most likely source of the disease was the graft,
LYODURA (Lot 2105), produced by B. Braun Melsungen AG, Federal
Republic of Germany (1). The CDC/FDA investigators were unable to
obtain the identity of the donor of the implicated graft or to
trace the disposition of other tissues from this donor. A
representative of the producer of LYODURA reported that the
company does not maintain records identifying donors and mixes
dura from multiple donors during processing of a single lot. As a
result of this investigation, FDA issued a Safety Alert on April
28, 1987, recommending disposal of all LYODURA from packages
bearing a 4 digit lot number beginning with the digit "2" (the
code for material packaged in 1982) as well as all unmarked
LYODURA (2).

CDC conducted a telephone survey of 10 other known producers of
dura mater used in the United States. All reported maintaining
records that allow identification and tracing of each donor of a
particular lot of product and of the recipient institution. In
addition, it was found that these producers process dura from
each donor individually so that there is no contact with or
co-mingling of dura from different donors.

Editorial Note

Editorial Note: Because of the differences between the processing
of LYODURA and of other products, LYODURA may carry a higher risk
of transmitting CJD than other dura mater products used in the
United States. As indicated in the FDA Safety Alert, current
procedures used to sterilize human dura mater are not adequate to
inactivate the CJD agent, and even the most stringent donor
screening cannot exclude asymptomatic prepatent carriers of CJD
(2). Thus, the use of any human dura mater product carries some
risk of transmission of CJD, and procedures that minimize the
risk are important. Alternatives to these products, such as
autologous fascia or synthetic materials, are available.

The potential for human tissue products to transmit infectious
agents has been documented for several procedures other than this
single case in a recipient of a dura mater graft. There have been
reports of presumed transmission of rabies and CJD by corneal
transplantation (3,4), of human immunodeficiency virus (HIV) by
organ transplantation (5), and of hepatitis B and HIV by
artificial insemination (6,7).

The methods of production and distribution of human tissue
products are not routinely subjected to FDA inspection and
approval. Health care providers are urged to use human tissue
products that have been handled according to strict guidelines
such as those established by the American Association of Tissue
Banks (8). In addition, hospitals should maintain records so that
infections associated with human tissue products can be linked
with specific lot numbers of these products.

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